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Study on the Effects of Dronabinol and Palmidrol for Adults with Tourette Syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for Tourette's syndrome in adults. Tourette's syndrome is a condition characterized by repetitive movements or unwanted sounds, known as tics, that cannot be easily controlled. The treatment being tested is called SCI-110, which is taken as a soft capsule. It contains two active substances: dronabinol and palmidrol. Dronabinol is a chemical that is similar to a substance found in cannabis, and palmidrol is a compound that may help reduce inflammation and pain.

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of SCI-110 in treating adults with Tourette's syndrome. Participants in the study will take the medication daily. The study is designed to compare the effects of SCI-110 with a placebo, which looks like the medication but does not contain the active substances. This helps researchers understand how well the treatment works compared to no treatment. The study will last for a period of up to 12 weeks, during which participants will be monitored regularly to assess their response to the treatment and any side effects they may experience.

Throughout the study, participants will have regular check-ups to monitor their health, including vital signs like blood pressure and heart rate. The study aims to gather information on the number of adverse events, which are any unwanted effects that occur during the study. This information will help determine the safety and potential benefits of SCI-110 for people with Tourette's syndrome. The results of this study could provide valuable insights into new treatment options for managing the symptoms of this condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of Tourette's syndrome according to the DSM-5 criteria and ensuring that the total tic score is greater than 14.
Participants must have a stable medication dose for tics and any other conditions for at least six weeks before starting the trial.
Step 2
Baseline evaluation
A baseline evaluation is performed to record initial health metrics, including vital signs such as blood pressure and heart rate.
Women of child-bearing potential undergo a pregnancy test to ensure eligibility.
Step 3
Treatment phase 1
Participants receive a daily oral dose of SCI-110 in the form of a soft capsule. The active substances are dronabinol and palmidrol.
The treatment is administered orally each day for a specified period, as determined by the study protocol.
Step 4
Placebo phase
Participants are given a placebo, which is a non-active substance, in the form of a soft capsule. This phase is designed to compare the effects of the active medication against no active treatment.
The placebo is administered daily for a period specified in the study protocol.
Step 5
Treatment phase 2
Participants receive another daily oral dose of SCI-110 in the form of a soft capsule. This phase may involve a different formulation of the medication.
The treatment continues daily for a specified duration, as outlined in the study protocol.
Step 6
Follow-up evaluations
Regular follow-up evaluations are conducted to monitor the participant's health and any changes in symptoms. This includes recording vital signs and any adverse events.
The number and rate of adverse events, as well as any significant changes in health metrics, are documented at each visit.
Step 7
Final assessment
A final assessment is performed to evaluate the overall effects of the treatment. This includes a comprehensive review of health metrics and any adverse events experienced during the trial.
Participants are required to abstain from certain activities, such as sperm donation, for a period following the last administration of the study medication.

Who can join the trial?

10 criteria

Adults with **Tourette's syndrome** who are between **18 and 65 years old** and receive care outside of a hospital.
Diagnosis of **Tourette's syndrome** according to the **DSM-5**, which is a guide used by doctors to diagnose mental health conditions.
Both **men and women** can participate.
A **total tic score** greater than 14 on the **YGTSS-R**, which is a scale used to measure the severity of tics.
A score of 4 or higher on the **CGI-S**, which is a scale that measures the severity of a condition.
Any medication or treatment for tics and other conditions must be at a stable dose for at least 6 weeks before joining the study, and participants must agree to keep the dose stable during the study.
Participants must sign a written consent form and agree to follow the treatment and check-up procedures.
Participants must understand the study's experimental nature, as well as the possible risks and benefits.
Women who can have children must have a negative pregnancy test before starting the study medication and must use a highly effective birth control method during the study.
Men must agree to use a condom with partners during the study and for three months after the last dose of the study medication. They must also agree not to donate sperm for three months after the study ends.

Who cannot join the trial?

3 criteria

Patients who are not between the ages of 18 and 65 years old.
Patients who are not receiving care as out-patients, meaning they are not staying overnight in a hospital.
Patients who do not have Tourette's syndrome, which is a condition that causes people to make involuntary movements or sounds.

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Medizinische Hochschule Hannover
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Hanover, Germany

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Investigated drugs

SCI-110 is an experimental medication being tested for its effectiveness, safety, and tolerability in treating adults with Tourette Syndrome. It is taken orally on a daily basis. The study aims to determine how well this medication can help manage the symptoms of Tourette Syndrome, which often include involuntary movements and vocalizations.

Palmidrol

What is already known about the treatment

SCI-110 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating Tourette's syndrome in adults. It is not yet widely recognized in medical literature as a standard treatment, as it is still under investigation. The main therapeutic indication for SCI-110 is to manage symptoms associated with Tourette's syndrome. Its mechanism of action involves modulating neurotransmitter activity in the brain, which may help reduce tics and other related symptoms. SCI-110 is classified pharmacologically as a central nervous system agent.

Investigated diseases

Tourette's Syndrome – This is a neurological disorder characterized by repetitive, involuntary movements and vocalizations called tics. It typically begins in childhood, but in this study, it is focused on adults aged 18 to 65. The tics can vary in frequency and intensity, and they may change over time. Motor tics might include blinking, shrugging, or other movements, while vocal tics can involve sounds like grunting or throat clearing. The condition can fluctuate, with periods of increased tic activity followed by times of relative calm. It is important to note that the severity and type of tics can differ greatly among individuals.